NCT00493298

Brief Summary

The primary objective of this study is to assess the long-term safety and impact on disease activity and progression of Tysabri in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
6,620

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

Longer than P75 for all trials

Geographic Reach
18 countries

419 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2007

Completed
1 day until next milestone

Study Start

First participant enrolled

June 29, 2007

Completed
16.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

16.4 years

First QC Date

June 27, 2007

Last Update Submit

April 5, 2024

Conditions

Keywords

disease progressionMultiple Sclerosisdisease activityTysabrinatalizumablong-term safety

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Serious Adverse Events (SAE)

    Up to 15 years

Secondary Outcomes (9)

  • Annualized Relapse Rate (ARR)

    Yearly for up to 15 years

  • Distribution of the Total Number of Relapses

    Yearly for up to 15 years

  • Time to First Relapse

    Yearly for up to 15 years

  • Percentage of Participants with Relapse

    Yearly for up to 15 years

  • Percentage of Participants with Disability Progression

    Yearly for up to 15 years

  • +4 more secondary outcomes

Study Arms (1)

Tysabri

According to the local prescribing information

Drug: Tysabri

Interventions

According to the local prescribing information

Also known as: BG00002, natalizumab
Tysabri

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with RRMS who are therapy-naïve to Tysabri and who meet the criteria defined in the indication statement for prescription in the respective country.

You may qualify if:

  • Documented diagnosis of Relapsing Remitting Multiple Sclerosis
  • The decision to treat with Tysabri must precede enrollment
  • Patient must be a new Tysabri user, and must not have had more than 3 Tysabri infusions prior to enrollment
  • Must have had at least one relapse in the previous year, and must satisfy locally approved therapeutic indications for Tysabri

You may not qualify if:

  • History of Progressive Multifocal Leukoencephalopathy or other opportunistic infections, or an increased risk of opportunistic infections
  • History of positive anti-Tysabri antibodies
  • Concomitant Immunomodulatory or immunosuppressive therapy during therapy with Tysabri
  • Patient immunocompromised at the time of enrollment
  • Known active malignancy
  • Women must not be breast feeding or pregnant, or planning to become pregnant (must use birth control unless surgically sterile)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (419)

Research Site

Buenos Aires, 8000, Argentina

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Buenos Aires, C1061ABD, Argentina

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Buenos Aires, C1118AAT, Argentina

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Buenos Aires, C1428AQK, Argentina

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CABA, C1015ABR, Argentina

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Córdoba, X5014HYR, Argentina

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Santa Fe, S2000BZL, Argentina

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Camperdown, New South Wales, 2050, Australia

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Liverpool, New South Wales, 2170, Australia

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New Lambton Heights, New South Wales, 2305, Australia

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St Leonards, New South Wales, 2065, Australia

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Auchenflower, Queensland, 4066, Australia

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Gold Coast, Queensland, 9726, Australia

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Adelaide, South Australia, 5042, Australia

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North Adelaide, South Australia, 5006, Australia

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Box Hill, Victoria, 3128, Australia

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Fitzroy, Victoria, 3065, Australia

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Heidelberg, Victoria, 3084, Australia

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Melbourne, Victoria, 3004, Australia

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Parkville, Victoria, 3050, Australia

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Nedlands, Western Australia, 6009, Australia

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Aalst, 9300, Belgium

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Anderlecht, 1070, Belgium

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Antwerp, 2020, Belgium

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Bocholt, 3950, Belgium

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Brasschaat, 2930, Belgium

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Bruges, 8000, Belgium

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Brussels, 1000, Belgium

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Brussels, 1180, Belgium

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Charleroi, 6000, Belgium

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Charleroi, B-6042, Belgium

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Edegem, 2650, Belgium

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Fraiture, 4557, Belgium

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Genk, 3600, Belgium

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Ghent, 9000, Belgium

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Hasselt, 3500, Belgium

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Jette, 1090, Belgium

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Kortrijk, 8500, Belgium

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La Louvière, 7100, Belgium

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Leuven, 3000, Belgium

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Libramont, 6800, Belgium

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Liège, 4000, Belgium

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Malmedy, 4960, Belgium

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Melsbroek, 1820, Belgium

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Ostend, 8400, Belgium

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Ottignies, 1340, Belgium

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Overpelt, 3900, Belgium

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Sijsele, 8340, Belgium

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Tournai, 7500, Belgium

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Wilrijk, 2610, Belgium

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Woluwe-Saint-Lambert, 1200, Belgium

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Belo Horizonte, 30130-090, Brazil

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Botucatu, 18618-687, Brazil

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Rio de Janeiro, 21941-590, Brazil

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São Paulo, 05402-000, Brazil

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São Paulo, 2151-1233, Brazil

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Edmonton, Alberta, T5H 4B9, Canada

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Burnaby, British Columbia, V5G2X6, Canada

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Vancouver, British Columbia, V6T 2B5, Canada

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Winnipeg, Manitoba, R3E0T5, Canada

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Saint John, New Brunswick, E2L 4L2, Canada

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Halifax, Nova Scotia, B3HIV7, Canada

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Bracebridge, Ontario, P1L 1R1, Canada

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Guelph, Ontario, N1H4J4, Canada

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Hamilton, Ontario, L8L5G4, Canada

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Hamilton, Ontario, L8N 1T8, Canada

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London, Ontario, N6A5A5, Canada

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Milton, Ontario, L9T 7H3, Canada

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Thunder Bay, Ontario, P7B7C7, Canada

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Toronto, Ontario, M5B 1W8, Canada

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Gatineau, Quebec, J8Y 1W2, Canada

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Greenfield Park, Quebec, J4V 2J2, Canada

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Montreal, Quebec, H2X OA9, Canada

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Montreal, Quebec, H3A 2B4, Canada

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Regina, Saskatchewan, S4S3K8, Canada

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Brno, 62500, Czechia

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Brno, 65691, Czechia

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České Budějovice, 37087, Czechia

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Hradec Kralové, 50005, Czechia

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Jihlava, 58633, Czechia

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Olomouc, 77520, Czechia

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Ostrava, 70852, Czechia

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Pardubice, 53203, Czechia

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Pilsen, 30460, Czechia

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Prague, 10034, Czechia

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Prague, 12808, Czechia

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Prague, 14200, Czechia

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Prague, 15006, Czechia

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Teplice, 41528, Czechia

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Teplice, 41529, Czechia

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Zlín, 76275, Czechia

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Helsinki, 00029, Finland

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Jyväskylä, 40620, Finland

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Kuopio, 70211, Finland

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Pori, 28500, Finland

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Seinäjoki, 60220, Finland

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Tampere, 33521, Finland

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Turku, 20521, Finland

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Agen, 47923, France

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Aix-en-Provence, 13100, France

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Alençon, 61014, France

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Angoulême, 16000, France

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Research site ,1 Allée du Château- Dr Wagner

Ars-Laquenexy, 57245, France

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Auxerre, 89011, France

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Avranches, 50300, France

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Bayonne, 64100, France

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Beauvais, 60000, France

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Belfort, 90000, France

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Beuvry, 62660, France

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Béthune, 62408, France

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Boulogne-sur-Mer, 62321, France

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Calais, 62107, France

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Castelnau-le-Lez, 34171, France

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Castres, 81108, France

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Chambéry, 73000, France

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Chambéry, 73011, France

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Colmar, 68024, France

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Compiègne, 60321, France

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Dieppe, 76200, France

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Dreux, 28107, France

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Dunkirk, 59385, France

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Épinal, 88021, France

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Évreux, 27015, France

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Haguenau, 67501, France

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La Rochelle, 17000, France

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Research site 177, rue de Versailles- Dr Servan

Le Chesnay, 78157, France

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Le Chesnay, 78157, France

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Le Coudray, 28630, France

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Le Havre, 76600, France

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Le Mans, 72037, France

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Lille, 59000, France

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Lisieux, 14100, France

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Lomme, 59462, France

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Mantes-la-Jolie, 78201, France

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Maubeuge, 59600, France

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Metz, 57038, France

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Metz-Tessy, 74370, France

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Mont-de-Marsan, 40024, France

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Montauban, 82000, France

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Montluçon, 03100, France

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Montpellier, 34080, France

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Montpellier, 34264, France

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Mulhouse, 68100, France

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Nice, 06105, France

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Paris, 75020, France

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Paris, 75674, France

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Pau, 64000, France

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Quimper, 29000, France

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Reims, 51100, France

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Saint-Aubin-sur-Scie, 76550, France

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Sarreguemines, 57200, France

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Saumur, 49400, France

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St-Malo, 35400, France

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Talant, 21240, France

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Tarbes, 65013, France

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Tourcoing, 59200, France

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Trappes, 78190, France

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Trélazé, 49800, France

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Valenciennes, 59322, France

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Vesoul, 70014, France

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Vichy, 3201, France

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Abensberg, 93326, Germany

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Andernach, 56626, Germany

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Arnsdorf, 01477, Germany

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Asperg, 71679, Germany

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Augsburg, 86156, Germany

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Bad Hersfeld, 36088, Germany

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Bad Honnef, 53604, Germany

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Bad Kissingen, 97688, Germany

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Bad Mergentheim, 97980, Germany

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Bad Reichenhall, 83435, Germany

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Bamberg, 96049, Germany

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Berlin, 10017, Germany

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Berlin, 10437, Germany

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Berlin, 10785, Germany

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Berlin, 10969, Germany

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Berlin, 12057, Germany

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Berlin, 12099, Germany

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Berlin, 12203, Germany

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Berlin, 13347, Germany

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Berlin, 13439, Germany

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Berlin, 14163, Germany

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Bielefeld, 33602, Germany

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Bielefeld, 33647, Germany

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Bochum, 44791, Germany

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Bogen, 94327, Germany

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Bonn, 53111, Germany

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Bruchsal, 76646, Germany

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Buchholz, 21244, Germany

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Celle, 29223, Germany

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Chemnitz, 09117, Germany

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Cologne, 50924, Germany

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Cologne, 50996, Germany

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Dillingen, 66763, Germany

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Dresden, 01067, Germany

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Duisburg, 47169, Germany

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Düren, 52351, Germany

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Düsseldorf, 40211, Germany

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Düsseldorf, 40225, Germany

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Eisenach, 99817, Germany

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Emden, 26721, Germany

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Emmendingen, 79312, Germany

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Erbach im Odenwald, 64711, Germany

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Erlangen, 91054, Germany

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Essen, 45122, Germany

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Essen, 45138, Germany

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Essen, 45257, Germany

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Falkenstein, 61462, Germany

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Frankfurt, 60325, Germany

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Freiburg im Breisgau, 79106, Germany

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Görlitz, 02828, Germany

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Göttingen, 37073, Germany

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Greifswald, 17489, Germany

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Halle, 06120, Germany

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Hamburg, 20249, Germany

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Hamburg, 20354, Germany

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Hamburg, 22179, Germany

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Heidelberg, 69120, Germany

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Herford, 32052, Germany

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Itzehoe, 25524, Germany

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Jena, 07740, Germany

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Kaiserslautern, 67655, Germany

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Kaltenkirchen, 24568, Germany

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Kandel, 76870, Germany

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Kassel, 34121, Germany

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Kastellaun, 56288, Germany

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Kirchberg, 08107, Germany

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Kirchheim unter Teck, 73230, Germany

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Kreuzau, 52372, Germany

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Ladenburg, 68526, Germany

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Leipzig, 041579, Germany

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Leipzig, 04275, Germany

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Lengerich, 49525, Germany

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Ludwigshafen, 67059, Germany

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Lüdenscheid, 58511, Germany

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Lüdenscheid, 58515, Germany

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Lüneburg, 21335, Germany

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Magdeburg, 39120, Germany

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Mannheim, 68158, Germany

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Mannheim, 68161, Germany

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Marburg, 35043, Germany

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München, 80331, Germany

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München, 80333, Germany

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München, 81479, Germany

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München, 81675, Germany

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München, 81825, Germany

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Münster, 48149, Germany

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Neuburg am Inn, 86633, Germany

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Neukirchen-Vluyn, 47506, Germany

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Neuruppin, 16816, Germany

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Nuremberg, 90419, Germany

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Nuremberg, 90451, Germany

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Nuremberg, 90461, Germany

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Oldenburg, 26121, Germany

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Oldenburg, 26127, Germany

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Olpe, 57462, Germany

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Osnabrück, 49074, Germany

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Osnabrück, 49076, Germany

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Osnabrück, 49078, Germany

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Paderborn, 33098, Germany

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Potsdam, 14471, Germany

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Regensburg, 93053, Germany

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Remscheid, 42853, Germany

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Rüdersdorf, 15562, Germany

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Rülzheim, 76761, Germany

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Schlüchtern, 36381, Germany

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Schorndorf, 73614, Germany

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Schwaebisch, 74523, Germany

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Siegen, 57076, Germany

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Sinsheim, 74889, Germany

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Stade, 21682, Germany

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Stadtroda, 07646, Germany

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Stuttgart, 70176, Germany

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Stuttgart, 70182, Germany

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Tegel, 13507, Germany

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Teupitz, 15755, Germany

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Trier, 54282, Germany

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Troisdorf, 53844, Germany

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Ulm, 89073, Germany

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Ulm, 89077, Germany

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Ulm, 89081, Germany

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Unterhaching, 82008, Germany

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Wasserburg, 83512, Germany

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Weimar, 99425, Germany

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Weinheim, 69469, Germany

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Wermsdorf, 04779, Germany

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Wernigerode, 38855, Germany

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Wiesbaden, 65185, Germany

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Wolfenbüttel, 38300, Germany

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Wolfratshausen, 82515, Germany

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Würzburg, 97080, Germany

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Zwickau, 08058, Germany

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Heraklion, Crete, 71201, Greece

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Alexandroupoli, 68100, Greece

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Athens, 10676, Greece

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Athens, 11521, Greece

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Athens, 11524, Greece

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Athens, 11525, Greece

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Athens, 11526, Greece

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Ioannina, 45500, Greece

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Pátrai, 26504, Greece

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Pátrai, 26535, Greece

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Thessaloniki, 54636, Greece

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Thessaloniki, 56429, Greece

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Thessaloniki, 57010, Greece

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Bari, 70121, Italy

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Bergamo, 24126, Italy

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Cagliari, 09100, Italy

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Cefalù, 90015, Italy

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Chieti, 66013, Italy

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Cuneo, 11100, Italy

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Fidenza, 43036, Italy

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Florence, 50134, Italy

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Foggia, 71100, Italy

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Gallarate, 21013, Italy

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Milan, 20122, Italy

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Milan, 20133, Italy

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Napoli, 80131, Italy

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Orbassano, 10043, Italy

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Roma, 00144, Italy

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Roma, 00152, Italy

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Roma, 00185, Italy

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Zapopan, Jalisco, 45150, Mexico

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Monterrey, Nuevo León, 64060, Mexico

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Monterrey, Nuevo León, 64380, Mexico

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Aguascalientes, 20230, Mexico

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Estado de México, 52763, Mexico

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León, 37150, Mexico

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Mexico City, 01030, Mexico

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Mexico City, 05300, Mexico

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Mexico City, 06700, Mexico

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Mexico City, 06760, Mexico

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Mexico City, 09220, Mexico

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Mexico City, 14260, Mexico

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Puebla City, 72540, Mexico

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Puebla City, 91919, Mexico

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San Luis Potosí City, 78399, Mexico

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's-Hertogenbosch, 5223 GZ, Netherlands

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Almelo, 7600 SZ, Netherlands

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Blaricum, 1261 AN, Netherlands

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Breda, 4818 CK, Netherlands

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Eindhoven, 5602 ZA, Netherlands

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Geldrop, 5664 EH, Netherlands

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Gouda, 2803 HH, Netherlands

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Heerenveen, 8441 PW, Netherlands

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Heerlen, 6419 PC, Netherlands

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Helmond, 5700 AB, Netherlands

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Hengelo, 7550 AM, Netherlands

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Hoorn, 1624 NP, Netherlands

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Leeuwarden, 8934 AD, Netherlands

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Meppel, 7943 SM, Netherlands

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Nieuwegein, 3430 EM, Netherlands

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Nijmegen, 6500 GS, Netherlands

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Roermond, 6043 CV, Netherlands

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Rotterdam, 3079 DZ, Netherlands

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Sittard-Geleen, 6162 BG, Netherlands

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The Hague, 2566 MJ, Netherlands

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Tilburg, 5022 GC, Netherlands

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Venray, 5801 CE, Netherlands

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Woerden, 3447 GN, Netherlands

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Zwolle, 8011 JW, Netherlands

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Bergen, 5021, Norway

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Bodø, 8092, Norway

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Drammen, 3004, Norway

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Fredrikstad, 1603, Norway

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Førde, 6812, Norway

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Haugesund, 5504, Norway

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Lillehammer, 2629, Norway

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Lørenskog, 1478, Norway

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Molde, 6407, Norway

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Namsos, 7800, Norway

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Oslo, 0027, Norway

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Oslo, 0407, Norway

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Skien, 3710, Norway

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Stavanger, 4095, Norway

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Tromsø, 9038, Norway

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Trondheim, 7006, Norway

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Tønsberg, 3103, Norway

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Aveiro, 3810-095, Portugal

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Beja, 7801-849, Portugal

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Evora, 7000-811, Portugal

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Funchal, 9000, Portugal

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Lisbon, 1349-019, Portugal

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Lisbon, 1649-035, Portugal

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Porto, 4200 - 319, Portugal

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Setúbal, 2910-446, Portugal

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Banská Bystrica, 975 17, Slovakia

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Bratislava, 813 69, Slovakia

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Bratislava, 826 06, Slovakia

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Bratislava, 833 05, Slovakia

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Košice, 041 66, Slovakia

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Nitra, 949 01, Slovakia

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Ávila, 05071, Spain

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Badalona, 08916, Spain

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Barcelona, 08003, Spain

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Barcelona, 08907, Spain

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Donostia / San Sebastian, 20014, Spain

Location

Research site

Girona, 17007, Spain

Location

Research site

Langreo, 33920, Spain

Location

Research site

Logroño, 26006, Spain

Location

Research site

Palma de Mallorca, 07014, Spain

Location

Research site

Ponferrada, 24411, Spain

Location

Research site

Tarragona, 43003, Spain

Location

Research site

Tarragona, 43500, Spain

Location

Research site

Vitoria-Gasteiz, 01009, Spain

Location

Research site

Edgbaston, Birmingham, B15 2TH, United Kingdom

Location

Research site

Canterbury, Kent, CT1 3NG, United Kingdom

Location

Research site

Hammersmith, London, W6 8RF, United Kingdom

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Research site

Salford, Manchester, M6 8HD, United Kingdom

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Research site

Belfast, BT16 1RH, United Kingdom

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Research site

Brighton, BN2 5BE, United Kingdom

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Research site

Bristol, BS16 1LE, United Kingdom

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Research site

Coventry, CV2 2DX, United Kingdom

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Research site

Exeter, EX25DW, United Kingdom

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Research site

Liverpool, L9 7LJ, United Kingdom

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Research site

Middlesbrough, TS4 3BW, United Kingdom

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Research site

Newcastle upon Tyne, NE1 4LP, United Kingdom

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Research site

Nottingham, NG7 2UH, United Kingdom

Location

Research site

Stoke-on-Trent, ST4 6QG, United Kingdom

Location

Related Publications (3)

  • Butzkueven H, Kappos L, Spelman T, Trojano M, Wiendl H, Su R, Liao S, Hyde R, Licata S, Ho PR, Campbell N. No evidence for loss of natalizumab effectiveness with every-6-week dosing: a propensity score-matched comparison with every-4-week dosing in patients enrolled in the Tysabri Observational Program (TOP). Ther Adv Neurol Disord. 2021 Sep 27;14:17562864211042458. doi: 10.1177/17562864211042458. eCollection 2021.

  • Butzkueven H, Kappos L, Wiendl H, Trojano M, Spelman T, Chang I, Kasliwal R, Jaitly S, Campbell N, Ho PR, Licata S; Tysabri Observational Program (TOP) Investigators. Long-term safety and effectiveness of natalizumab treatment in clinical practice: 10 years of real-world data from the Tysabri Observational Program (TOP). J Neurol Neurosurg Psychiatry. 2020 Jun;91(6):660-668. doi: 10.1136/jnnp-2019-322326. Epub 2020 Mar 31.

  • Butzkueven H, Kappos L, Pellegrini F, Trojano M, Wiendl H, Patel RN, Zhang A, Hotermans C, Belachew S; TYSABRI Observational Program (TOP) Investigators. Efficacy and safety of natalizumab in multiple sclerosis: interim observational programme results. J Neurol Neurosurg Psychiatry. 2014 Nov;85(11):1190-7. doi: 10.1136/jnnp-2013-306936. Epub 2014 Feb 14.

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingDisease ProgressionMultiple Sclerosis

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2007

First Posted

June 28, 2007

Study Start

June 29, 2007

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

April 8, 2024

Record last verified: 2024-04

Locations